FDA Label for Sunburn Relief Gel

View Indications, Usage & Precautions

Sunburn Relief Gel Product Label

The following document was submitted to the FDA by the labeler of this product Jell Pharmaceuticals Pvt. Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Lidocaine HCl 0.5%


Purpose



External analgesic


Uses



for the temporary relief of pain and itching associated with

  • minor burns
  • sunburn
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations

Warnings



For external use only


When Using This Product



avoid contact with the eyes


Do Not Use



in large quantities, particularly over raw surfaces or blistered areas


Stop Use And Ask A Doctor If



condition worsens, or if symptoms persist for more than 7 days or clean up and occur again within a few days


Keep Out Of Reach Of Children



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Inactive Ingredients



water, propylene glycol, glycerin, Aloe Barbadensis Leaf Juice, sodium hydroxide, isopropyl alcohol, polysorbate 80, carbomer, phenoxyethanol, benzyl alcohol, menthol, disodium EDTA, blue 1, yellow 5


Principl Display Panel



sunburn relief gel

Pain Relieving Gel

with Aloe Vera and Lidocaine HCl


* Please review the disclaimer below.